NCT05306717

Brief Summary

This observational study assesses whether the use of the QPGE has an impact on the rates of isolation and mechanical restraint in adult psychiatric admission units. It is supplemented by a qualitative survey that will collect the experience of caregivers using the QPGE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

1.8 years

First QC Date

March 14, 2022

Last Update Submit

June 17, 2024

Conditions

Keywords

Psychiatric DisorderPreventionMechanical restraintIsolation

Outcome Measures

Primary Outcomes (2)

  • Rate of isolation measures.(%)

    Isolation and/or restraint notified in the registers dedicated to the monitoring of measures restricting liberty in the admission units during the study period

    up to 1 year

  • Rate of restraint measures.(%)

    Isolation and/or restraint notified in the registers dedicated to the monitoring of measures restricting liberty in the admission units during the study period

    up to 1 year

Secondary Outcomes (5)

  • Rate of isolation measures not associated with an episode of mechanical restraint (%)

    up to 1 year

  • Duration of isolation measures not associated with an episode of mechanical restraint. (hours)

    up to 1 year

  • Rate of mechanical restraint measures (%)

    up to 1 year

  • Duration of mechanical restraint measures (hours)

    up to 1 year

  • User satisfaction score at the end of hospitalization

    up to 1 year

Study Arms (1)

Epidemiology

The study will compare the rates of isolation and restraint of the two sectoral admission units welcoming people in care without consent for a period of one year.

Other: Questionnaire

Interventions

The study will compare the rates of isolation and restraint of the two sectoral admission units welcoming people in care without consent for a period of one year. The impact of the QPGE on the satisfaction scores will be systematically evaluated by a self-questionnaire for patients at the end of hospitalization. The QPGE is administered by a nurse during the reception interview of the patient in the unit.

Epidemiology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with psychiatric disorders and hospitalized in a sectoral admission unit receiving patients in care without consent

You may qualify if:

  • Have been hospitalized in psychiatric admission unit with an entry date between January 1, 2020 and December 31, 2020
  • Be at least 18 years old at the time of hospitalization
  • Master the French language in order to have benefited from the QPGE and the satisfaction questionnaire

You may not qualify if:

  • Being the subject of an isolation and/or restraint measure, decided in another unit before, during the transfer to the study places
  • To have objected to the use of data collected during hospitalization following the information in the welcome booklet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Charles Perrens

Bordeaux, Gironde, 33000, France

Location

Related Publications (4)

  • Beghi M, Peroni F, Gabola P, Rossetti A, Cornaggia CM. Prevalence and risk factors for the use of restraint in psychiatry: a systematic review. Riv Psichiatr. 2013 Jan-Feb;48(1):10-22. doi: 10.1708/1228.13611.

  • Riahi S, Thomson G, Duxbury J. An integrative review exploring decision-making factors influencing mental health nurses in the use of restraint. J Psychiatr Ment Health Nurs. 2016 Mar;23(2):116-28. doi: 10.1111/jpm.12285. Epub 2016 Jan 26.

  • Bowers L, Allan T, Simpson A, Nijman H, Warren J. Adverse incidents, patient flow and nursing workforce variables on acute psychiatric wards: the Tompkins Acute Ward Study. Int J Soc Psychiatry. 2007 Jan;53(1):75-84. doi: 10.1177/0020764007075011.

  • Bowers L, Alexander J, Bilgin H, Botha M, Dack C, James K, Jarrett M, Jeffery D, Nijman H, Owiti JA, Papadopoulos C, Ross J, Wright S, Stewart D. Safewards: the empirical basis of the model and a critical appraisal. J Psychiatr Ment Health Nurs. 2014 May;21(4):354-64. doi: 10.1111/jpm.12085. Epub 2014 Jan 24.

MeSH Terms

Conditions

Mental Disorders

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Vincent BILLE

    Advanced Practice Nurse

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 1, 2022

Study Start

April 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations